Top of the morning to you. Although mounds of snow continue to engulf the Pharmalot campus, we are as chipper as ever. The shortest of short people is leaving for the local schoolhouse, and the official mascots are happily lounging in the official Pharmalot lounge. As for us, we are brewing our mandatory cups of stimulation and invite you to join us. Remember, no prescription is required. So time to get cracking. Here are some tidbits. Hope you conquer the world today and, of course, that you will keep in touch …
A federal court judge modified the conditions of Martin Shkreli’s bail so that he can travel to Washington, D.C., and testify before the House Committee on Oversight and Government Reform in a Feb. 4 hearing. The committee threatened Shkreli with contempt of court charges if he failed to appear after he cited his travel restrictions. However, Shkreli may still plea the Fifth Amendment to avoid incriminating himself in a securities fraud case.
US Senator Edward Markey (D-Mass.) is using Senate rules to block the nomination of Dr. Robert Califf as commissioner of the Food and Drug Administration. Markey told The Boston Globe that he is trying to force the agency to reverse its approval last year of OxyContin, the controversial opioid painkiller, for children and also change its regulatory approach to approving such drugs.
In the wake of the tragedy involving an early-stage clinical trial in France in which one person died, the FDA says it is collecting and reviewing safety information concerning FAAH inhibitors being developed in the US. The agency is also “conferring” with European regulators. FAAH is an enzyme produced in the brain that breaks down neurotransmitters known as endocannabinoids.
Donald Trump told a New Hampshire crowd that he could save Medicare $300 billion by allowing the Centers for Medicare and Medicaid Services to negotiate directly with drug makers, Politico writes. This is the same position that Democrats have supported, although it is opposed by Republicans. “We don’t do it,” he said. “Why? Because of the drug companies.”
The FDA plans to publish a long list of guidances this year, including one for interchangeability among biosimilars and the use of links to third-party sites for Internet advertising, according to this notice.
GlaxoSmithKline is running feasibility studies to determine whether its vaccine technology can combat the Zika virus, which has been linked to brain damage in babies in Brazil, Reuters reports.
Shire has re-filed an application with the FDA for its lifitegrast eye drug after the treatment was rejected following a priority review last October, Pharma Times writes.
Vietnam is urging India’s drug makers to establish units as part of a “Make in Vietnam” initiative, according to The Economic Times.